Does the eClinicalWorks Settlement Shine a Light on Patient Safety, Interoperability Issues?

This is the second story in a two-part article that examines the potential impact of the eClinicalWorks settlement on health IT policy and the vendor market

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The first part of this two-part article was published on Wednesday and can be read here.

Some health IT leaders view the recent settlement of a False Claims Act lawsuit against electronic health records software vendor eClinicalWorks as shining a spotlight on the need for a stronger focus on health IT-related patient safety, and on the lack of interoperability within the industry. What are the potential policy implications of the eClinicalWorks settlement? And, what could be the ripple effects in the EHR vendor market?

Last month, the U.S. Department of Justice announced a settlement that holds eClinicalWorks, and the company’s founders and executives—Chief Executive Officer Girish Navani, Chief Medical Officer Rajesh Dharampuriya, M.D., and Chief Operating Officer Mahesh Navani—liable for payment of $155 million to resolve a False Claims Act lawsuit. The company allegedly violated federal law by misrepresenting the capabilities of its software and for allegedly paying kickbacks to certain customers in exchange for promoting its product, according to the Justice Department. Separately, an eClinicalWorks developer and two project managers were also found liable and will pay separate fines.

It is important to note that the Westborough, Mass.-based EHR vendor has not admitted any fault or wrongdoing and its software remains fully certified under the Meaningful Use program.

In response to a media request for an interview about the settlement, an eClinicalWorks spokesperson sent a letter that was sent to the company’s customers. In that letter, eClinicalWorks stated that it would, in addition to paying $155 million, bolster its compliance program. “The inquiry leading to the settlement primarily centered on technical aspects of the Meaningful Use program and allegations that eClinicalWorks software had technical non-conformities related to some of the criteria, all of which have since been addressed,” eClinicalWorks’ CEO Girish Navani stated in the letter.

As noted in the previous story, the Justice Department’s settlement with eClinicalWorks resolves allegations in a lawsuit filed in the District of Vermont by Brendan Delaney, a software technician formerly employed by the New York City Division of Health Care Access and Improvement. The lawsuit was filed under the whistleblower provisions of the False Claims Act.

Delaney was, at the time, a New York City government employee implementing the eClinicalWorks EHR system at Riker’s Island for prisoner healthcare when he first became aware of numerous software problems that he alleged put patients at risk, according to a press release issued by a law firm, Phillips & Cohen, representing Delaney.

According to the allegations in the whistleblower complaint, problems that were caused by eClinicalWorks EHR software included failure to keep an accurate record of current medications administered to patients, mistakenly including in a patient’s medical record information from another patient’s record, multiple errors with medication module, including failure to ensure proper dosages, errors with start/stop dates, failure to record changes to medications, duplicate orders for certain prescription drugs, and failure to display current medication at all in some instances and inaccurate tracking of laboratory results.

Many health IT industry leaders believe the eClinicalWorks case once again highlights the need for a federal patient safety center focused on health IT-related issues, a project proposed by the Office of the National Coordinator for Health Information Technology (ONC). In fact, two years ago, a task force of experts and health IT safety stakeholders convened by ONC crafted a roadmap to guide the development of a proposed national Health IT Safety Center, however, the initiative has not yet received federal funding.

Jeffrey Smith, vice president of public policy at the Washington, D.C.-based American Medical Informatics Association (AMIA), says, “This is something that AMIA has been advocating for a number of years, along with others, but we have yet to conjure the political will and the money to support a national health IT safety center.” He adds that the case puts a spotlight on the patient safety issues that arise at the intersection of health IT and healthcare. “It gets to the notion of shared responsibility; you can have a perfect system in the lab and it can do wonderfully in a testing scenario, but when you send it out to the real world and hook it up to other systems in a complex IT environment, there is no telling how many things can go wrong. I’m hopeful that as we learn more [about the eClinicalWorks case] it will encourage honest conversation around the need for a national health IT safety center.”

The False Claims Act case against eClinicalWorks also highlights problems in health IT that center on interoperability. The Justice Department, in its case against eClinicalWorks, contends that the vendor’s software failed to satisfy data portability requirements intended to permit healthcare providers to transfer patient data from eClinicalWorks’ software to the software of other vendors.

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